PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using the name Adalat LA 60mg Tablets but will be referred to as Adalat LA throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

■ Keep this leaflet. You may need to read it again.

■ If you have any further questions, ask your doctor or pharmacist.

■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Adalat LA is and what it is used for

2. What you need to know before you take Adalat LA

3. How to take Adalat LA

4. Possible side effects

5. How to store Adalat LA

6. Contents of the pack and other information

1. What Adalat LA is and what it is used for

Adalat LA contains nifedipine, which belongs to a group of medicines called calcium antagonists.

Adalat LA is used to treat high blood pressure or angina (chest pain).

For high blood pressure: Adalat LA works by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.

For angina: Adalat LA works by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it.

Your angina attacks will be less severe and less frequent if there is less strain on the heart.

2. What you need to know before you take Adalat LA

Do not take Adalat LA:

■ If you have had a heart attack within the last month.

■ If you get a sudden angina attack. Adalat LA will not help relieve symptoms of angina quickly.

■ If you have unstable angina.

■ If you are allergic to nifedipine, any other similar medicines (known as dihydropyridines) or any of the other ingredients of this medicine (listed in section 6).

■ If you are taking rifampicin, an antibiotic.

■ If you have a liver disease that prevents your liver from working properly.

■ If you have inflammation of the bowel or

intestines, such as Crohn's disease.

■ If you have an obstruction or narrowing in your intestines, or have had this in the past.

■ If you have ever had an obstruction in the gullet

(the oesophagus - the tube connecting the throat to the stomach).

■ If you have been told that you have a narrowing of the aortic heart valve (stenosis).

■ If you have ever had a collapse caused by a heart problem (cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.

■ If you have a "Kock pouch" (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut.

Adalat LA with food and drink

You can take Adalat LA with or without food.

Do not drink grapefruit juice or eat grapefruit while taking Adalat LA

Do not start taking Adalat LA within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Adalat LA. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

One tablet of Adalat LA 60mg contains 48mg salt (sodium chloride).

Tell your doctor if you are on a low-salt diet.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You may be able to use Adalat LA but only after special consideration and agreement by your doctor.

Do not take Adalat LA if you are breast-feeding

If you need to take Adalat LA, you should stop breast-feeding before you start taking this medicine.

Driving and using machines

Adalat LA may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way. This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.

3. How to take Adalat LA

Adalat LA is specially formulated so that you only have to take one dose each day.

There is a memory aid on the blister packs for the daily intake.

The translation of the days of the week is as follows:

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

■ Dose for high blood pressure: the usual dose is 1 tablet, once a day.

■ Dose for angina: the dose depends on your individual requirements. Your doctor will decide how much you should take.

■ Swallow the tablets whole. Do not bite, chew or break them - if you do they will not work properly. If you have difficulty swallowing tablets, consult your doctor as he or she may wish to change your medicine.

■ Continue to take these tablets for as long as your doctor has told you to.

Take your dose at the same time each day, preferably in the morning.

Take your tablets with a glass of water. Do not take them with grapefruit juice.

You can take Adalat LA with or without food.

You may see what looks like a complete tablet in the toilet or in your stools. This is normal - it's the outer shell of the tablet which is not digested by the body.

Use in children and adolescents:

Adalat LA is not recommended for use in children and adolescents below 18 years of age, because there is only limited data on the safety and efficacy in this population.

If you take more Adalat LA than you should

Get medical help immediately. If possible, take your tablets or the box with you to show the doctor.

Taking too many tablets may cause your blood pressure to become too low and your heartbeats to speed up or slow down. It may also lead to an increase in your blood sugar level or an increase in the acidity of your blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness.

If you forget to take Adalat LA

Take your normal dose immediately and continue taking your tablets at the usual time of day, waiting at least 12 hours before taking the next dose.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects

Other side effects

(Frequency not known: frequency cannot be estimated from the available data)

■ stomach pain or distress caused by a mass of foreign material found in the stomach which may require surgery for removal

■ difficulty swallowing

■ abdominal pain, caused by obstruction of the gut or ulcers in the gut

■ vomiting

■ a reduction in the number of white blood cells (leucopenia)

■ a more severe decrease in a specific class of white blood cell (agranulocytosis)

■ increased blood sugar (hyperglycaemia)

■ decreased skin sensitivity (hypoaesthesia)

■ drowsiness (somnolence)

■ eye pain

■ chest pain (angina pectoris)

■ heartburn or indigestion (gastroesophageal sphincter insufficiency)

■ yellowing of the whites of the eyes or skin (jaundice)

■ sensitivity to light (photosensitivity allergic reaction)

■ small, raised areas of bleeding in the skin (palpable purpura)

■ joint pain

■ muscle pain

All of these symptoms usually go away when treatment with Adalat LA is stopped.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adalat LA

■ Store in the original container. The tablets should be protected from strong light, so only remove the tablet from the container or blister strip when you are about to take it.

■ Do not store above 30°C.

■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

■ Do not use the tablets after the expiry date which is marked on both the outer carton and on each blister strip of tablets. The expiry date refers to the last date of the month.

■ If your doctor decides to stop the treatment, return any leftover tablets to the pharmacist. Only keep then if your doctor tells you to.

■ If the tablets appear discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.

■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.